Pain Outcomes After Anterior Cruciate Ligament Reconstruction With Posterior Capsular Marcaine Injection: A Prospective Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 23
- 主要终点
- VAS Scores
研究概览
简要总结
Post-operative pain control following elective anterior cruciate ligament reconstruction continues to be a hurdle for orthopaedic surgeons. This obstacle becomes particularly problematic during the first 36 hours after the operation, when the patient is experiencing pain at its peak intensity. Good control of pain leads to better patient comfort, confidence to place weight on the operative limb and improved ability to perform critical exercises in this period to improve joint range of motion.
A variety of anesthetic techniques have been employed to reduce pain including: cryotherapy, systemic analgesic and anti-inflammatory drugs, intrathecal, regional blockade of peripheral nerves and frequently intra-articular injections. Each technique has been studied at length with mixed but overall favorable results. However, in the authors' experience, after femoral nerve blockade, patients continue to complain of posterior knee pain in the Post-Anesthesia Care Unit (PACU) and peri-operative period. Intra-articular injections comprised of morphine and other Na-channel blocker analgesics may curb some of this pain by bathing the posterior capsule in anesthetic. However, there is still a large concern amongst orthopaedic surgeons about the potential harm these agents may have on the knee's healthy articular cartilage surfaces. The long term effects, including chondrolysis have been documented in the shoulder and while in the short term this effect is diminished there is still hesitation among surgeons to use this form of pain blockade.
This has led the investigators to adapt a technique of isolated posterior capsular injections after total knee replacements from the joint arthroplasty literature, which has shown favorable results with low complication risk. The investigators plan to study the effectiveness of this technique during ACL reconstruction in an attempt to curb the amount of posterior knee pain and decrease the overall narcotic use postoperatively while limiting the exposure of the native cartilage to harmful agents.
详细描述
A prospective series of consecutive patients undergoing primary ACLR will be recruited from a preoperative log of patients seeing one of two sports medicine fellowship trained surgeons within the investigators group. Patients undergoing primary unilateral anterior cruciate ligament reconstruction (ACLR) either with bone-patellar bone autograft or Achilles tendon allograft will be included by surgeons using similar techniques and fixation options.
After consenting to participate, subjects will be randomized into one of two groups. Using a random number generator, 60 consecutively enrolled patients will be placed in their appropriate study arm. (Odd numbers = Control Group) (Even numbers = Experimental Group). Only the patient will be blinded to which arm of the study they belong.
Group 1(Control) patients will undergo routine arthroscopically assisted ACLR surgery with a standardized postoperative protocol. Group 2 (Experimental) patients will undergo the same procedure with the same postoperative protocols as Group 1, with the addition of the posterior capsular injection of 20 cc of Marcaine 0.5%. There are no placebo treatments being offered and the surgeons and operating room staff are not blinded to the subjects group. Injecting marcaine in this study will be performed in accordance with its standard use according to the FDA labeling/guidelines. The physicians will use their discretion as to the appropriate location for the injection into the posterior capsule of the knee which should bring no additional risks than expected for a knee injection.
At the conclusion of the case, each patient will receive a dry sterile dressing, followed by a compression wrap and a hinged knee brace locked in extension. No drains, pain pumps or nerve stimulators will be used. The nurses in the recovery room who will be administering the VAS assessment and recording time and frequency of pain medication dosing will be blinded to the patients' Group number. The nurses will provide pain medications and the visual analog assessment for their duties in the post-op anesthesia unit, and are not administering drugs or procedures specifically for research purposes.
Post-operative Care All patients will be discharged home from the surgery center on the same day (within 2-3 hours) postoperatively. Patients will be made weight bearing as tolerated with crutches and a brace.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult individuals (ages 18-60), both sexes, submitted to elective ACL reconstructions with or without partial menisectomies of the medial or lateral meniscus
排除标准
- •Multiligamentous injury or revision surgery
- •Known narcotic/substance abuse or regular opiate use
- •Known allergy to any medication or anesthetic being used in this study
- •Patients with pre-existing diabetic or femoral neropathy
- •INTRAOPERATIVELY- if chrondral microfractures, inside-out or outside-in meniscal repairs were performed (***Since these additional surgeries within the joint may increase the perceived level of pain post-op***)
研究组 & 干预措施
No Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.
干预措施: Ice (Other)
No Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.
干预措施: Percocet (Drug)
No Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction and will NOT be receiving a posterior capsular knee injection of Marcaine 0.5%.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the INJECTION Arm of the study.
干预措施: Knee Brace and Crutches (Device)
Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.
干预措施: Marcaine (Drug)
Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.
干预措施: Ice (Other)
Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.
干预措施: Percocet (Drug)
Injection
These patients will receive standard of care when undergoing anterior cruciate ligament reconstruction but will additionally be receiving a one-time posterior capsular knee injection of Marcaine 0.5% (20cc) during the surgery.
They will be monitored for pain control and pill intake while in the PACU and the first four days post-operatively the same as the patients in the NO injection Arm of the study.
干预措施: Knee Brace and Crutches (Device)
结局指标
主要结局
VAS Scores
时间窗: Day 0-4 post-operatively
VAS Scales recorded in AM and PM
次要结局
- Pain Pill Count(Day 0-4 post-operatively)
研究者
Michael Banffy
Attending - PI
Cedars-Sinai Medical Center